A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation

Recruiting Phase 2 Phase 3 Interventional Study
Kidney Transplant Rejection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
526 (estimated)
Sponsor
Sanofi · Industry
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About This Trial
The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligibl…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants who are scheduled to receive their first kidney transplant from a living or deceased donor. * Participants with low to moderate immunological risk. Exclusion Criteria: * Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac deat…
Contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610

Contact-US@sanofi.com

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